Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
150121–150144 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 25, 1985
IDENTIFICATION STICKS OXIDASE
K844887 · JTO
Oxoid U.S.A., Inc.
Microbiology · 70d
Cleared Feb 25, 1985
SLT 225 WASHER/DISPENSER FOR MICRO TITERPLATES
K844891 · JTC
Slt Labinstruments, Inc.
Microbiology · 70d
Cleared Feb 25, 1985
SLT 220 WASHER FOR MICROITITERPLATES
K844892 · JTZ
Slt Labinstruments, Inc.
Microbiology · 70d
Cleared Feb 25, 1985
SLT 223 DISPENSER FOR MICROTITERPLATES
K844893 · JTC
Slt Labinstruments, Inc.
Microbiology · 70d
Cleared Feb 25, 1985
AZIDE AGAR W/5% SHEEP BLOOD
K844934 · JSI
American Laboratory Supply, Inc.
Microbiology · 68d
Cleared Feb 25, 1985
SCENTED BREATHABLE MINI-SHIELD PRIVATE LABEL BRAND
K844975 · HHL
I.C.D. Industries, Inc.
Obstetrics & Gynecology · 61d
Cleared Feb 25, 1985
CRYSTAL MANUAL BREAST PUMP
K850242 · HGY
Crystal Medical Products, Inc.
Obstetrics & Gynecology · 34d
Cleared Feb 25, 1985
CARDIAC CATHETERIZATION PACK
K850337 · DRE
Marwood Medical, Inc.
Cardiovascular · 28d
Cleared Feb 25, 1985
CARDIOVASCULAR SET UP
K850341 · DQO
Marwood Medical, Inc.
Cardiovascular · 28d
Cleared Feb 22, 1985
OMS CRYO
K844467
Optical Micro Systems, Inc.
Dental · 95d
Cleared Feb 22, 1985
INSTRUTAINER
K844672 · FRG
Intrumed, Inc.
General Hospital · 84d
Cleared Feb 22, 1985
CYTOSAFE NEEDLE
K844904 · LHI
Baxa Corp., Sub. of Cook Group, Inc.
General Hospital · 67d
Cleared Feb 22, 1985
SILVER SPOON ENTERAL FEEDING PUMP
K850098 · FRN
Sterling Medical Devices, Inc.
General Hospital · 42d
Cleared Feb 22, 1985
OMNIMED IV SOLUTION ADMINISTRATION SET
K850112 · FPA
Omni Intl., Inc.
General Hospital · 39d
Cleared Feb 22, 1985
C/PES 9201, ECG STRESS TESTING SYS
K850114 · DRT
Gould, Inc.
Cardiovascular · 39d
Cleared Feb 22, 1985
THERMAL DIFFUSION CEREBRAL BLOOD FLOW MONITOR
K850657 · LME
Flowtronics, Inc.
Neurology · 25d
Cleared Feb 21, 1985
LEUKOFIX R
K843873 · KGX
Beiersdorf, Inc.
General & Plastic Surgery · 142d
Cleared Feb 21, 1985
LEUKOPOR SURGICAL TAPE
K843874 · KGX
Beiersdorf, Inc.
General & Plastic Surgery · 142d
Cleared Feb 21, 1985
LEUKOSILK
K843875 · KGX
Beiersdorf, Inc.
General & Plastic Surgery · 142d
Cleared Feb 21, 1985
LEUKOFLEX SURGICAL TAPE
K843876 · KGX
Beiersdorf, Inc.
General & Plastic Surgery · 142d
Cleared Feb 21, 1985
S.E.T. TUBE
K843988 · BTR
Bfw Laboratories, Inc.
Anesthesiology · 133d
Cleared Feb 21, 1985
CPNOGARD CAPNOMETER 1250
K844010 · CCK
Novametrix Medical Systems, Inc.
Anesthesiology · 132d
Cleared Feb 21, 1985
X-RAY TUBESTANDS BUCKY STANDS & VETERINARY X-RAY
K844337 · IYB
Quality X-Ray Manufacturing, Inc.
Radiology · 105d
Cleared Feb 21, 1985
HAND CONTROLLED ELECTROSURGICAL PENCIL DISPOSABLE
K844372 · GEI
Consolidated Medical Equipment, Inc.
General & Plastic Surgery · 100d